Catalog Number

CS025

Brand Name

Sunset Halo Style Chinstrap

Version/Model Number

CS025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BTK

Product Code Name

Strap, Head, Gas Mask

Public Device Record Key

0935e089-e00b-425e-ab3c-9f60680f4b57

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Package DI Number

10848530081482

Quantity per Package

100

Contains DI Package

00848530081485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-